AZ gets EMA approval for heart drug Brilique

The EMA has granted pre-market approval for AZ's Brilique for use in preventing blood clots in patients with acute coronary syndromes

The European Medicines Agency (EMA) has granted AstraZeneca (AZ) pre-market approval for Brilique (ticagrelor), also known as Brilinta outside Europe, for its use in preventing blood clots in patients with acute coronary syndromes. The US Food and Drug Administration (FDA) said last week that it needed three more months to review the drug for approval in the US.

EMA's Committee for Medicinal Products for Human Use (CHMP) stated that the drug would reduce the risks of heart attacks when used in combination with aspirin. It is now subject to final approval by the European Commission and could be in use in Europe and the UK by spring 2011.

AZ are releasing the anti-clotting drug in order to compete in a market dominated by Plavix (clopidogrel), sanofi-aventis and Bristol-Myers Squibb's blockbuster heart drug and the second best-selling drug globally.

Anders Ekblom, executive vice-president for AZ's global medicines development said, "Brilique will provide an important treatment option for physicians."

Experts anticipate that Brilique will become a market leader and financial forecasts estimate that sales of the new drug could reach $2.31bn by 2015.